EP0621481A2 - Système pour analyser le contenu des échantillons liquides - Google Patents

Système pour analyser le contenu des échantillons liquides Download PDF

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Publication number
EP0621481A2
EP0621481A2 EP94105884A EP94105884A EP0621481A2 EP 0621481 A2 EP0621481 A2 EP 0621481A2 EP 94105884 A EP94105884 A EP 94105884A EP 94105884 A EP94105884 A EP 94105884A EP 0621481 A2 EP0621481 A2 EP 0621481A2
Authority
EP
European Patent Office
Prior art keywords
test
test elements
storage container
elements
test element
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP94105884A
Other languages
German (de)
English (en)
Other versions
EP0621481A3 (en
Inventor
Joerg Dr. Schreiber
Wilfried Dr. Schmid
Hans-Jürgen Dr. Kuhr
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Roche Diagnostics GmbH
Original Assignee
Roche Diagnostics GmbH
Boehringer Mannheim GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Roche Diagnostics GmbH, Boehringer Mannheim GmbH filed Critical Roche Diagnostics GmbH
Publication of EP0621481A2 publication Critical patent/EP0621481A2/fr
Publication of EP0621481A3 publication Critical patent/EP0621481A3/de
Withdrawn legal-status Critical Current

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00732—Identification of carriers, materials or components in automatic analysers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/4875—Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • G01N2035/00089—Magazines
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00732—Identification of carriers, materials or components in automatic analysers
    • G01N2035/00742—Type of codes
    • G01N2035/00782—Type of codes reprogrammmable code
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/805—Test papers
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/809—Incubators or racks or holders for culture plates or containers
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/11—Automated chemical analysis
    • Y10T436/112499—Automated chemical analysis with sample on test slide
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/11—Automated chemical analysis
    • Y10T436/113332—Automated chemical analysis with conveyance of sample along a test line in a container or rack

Definitions

  • the invention relates to a system for analyzing sample liquids, which includes a linear arrangement of test elements, a measuring arrangement for the detection of changes occurring on a test element and two or more test elements within the system, the test elements being protected by a device against the ingress of moisture .
  • the invention also includes storage containers for two or more test elements and test elements per se, which can be sealed against moisture due to their shape.
  • a method for analyzing sample liquids is possible which works without the use of liquid reagents.
  • Analysis systems are known in the prior art which make it possible to analyze individual parameters in sample liquids. Particularly in the field of medicine and environmental protection, there are systems that can be operated by less-trained people. Devices that work without the use of liquid reagents, which is often referred to as dry analysis, are easy to use. For example, devices are used for the determination of glucose in the blood, in which the patient places blood on a test strip and carries out the measurement in an easy-to-use device. In the analysis systems with dry reagents customary in the prior art, the test elements are present separately outside the measuring device.
  • Known measuring devices have an opening, generally a slot, into which test strips can be inserted.
  • Guide elements ensure that a test strip is inserted in the intended orientation. Since the test strip is inserted manually into the device, there must be design features of the device that ensure the desired positioning of the test strip. This is usually implemented by a limitation that prevents insertion beyond a predetermined target position.
  • the most common systems use analytical tests based on color changes. The color change occurring on the test strip can be detected by reflection photometry. A measurement in transmission is also possible, but at least partially requires transparent test strips.
  • the devices required for photometry for generating and detecting radiation are known in principle in the prior art.
  • test strips have a test field and a holder of this test field, which enables handling.
  • the test field itself can consist of several layers. For example, layers of fleece are used for determinations in the blood which separate the cells from the serum. Layers in which reactions take place or which contribute to metering the analyte are also common.
  • the possible structure of a test strip is described, for example, in patent application EP-A-0271854.
  • the detection of an analyte can only be detected in a few cases by the direct formation of a dye, but a chain of chemical and / or biochemical reactions usually takes place, which result in the formation or decomposition of a dye.
  • test elements known in the prior art are in the form of a strip or a flat rectangular plate. Paper, special cardboard and plastics are commonly used as materials. The test field is applied to the materials mentioned either by soaking the material or in the form of additional layers. The storage stability of many test elements is greatly reduced by the effect of moisture, which is why commercially available test elements are either sealed individually or packaged in larger quantities. Sealing is usually done in plastic-laminated metal foils, preferably aluminum laminates. This form of packaging is found primarily in rapid tests that are evaluated visually.
  • test strips that are used repeatedly by the same person, e.g. B. in the determination of glucose in blood, there are generally several in containers made of moisture-impermeable materials, which also contain desiccants to absorb moisture.
  • the measurement process with known systems for analysis with dry reagents is carried out using an analysis device and separate test strips.
  • the user of the system manually opens a storage container, removes a test strip and closes the storage container in order to protect test strips remaining in the container from moisture.
  • a liquid to be analyzed is applied to the reaction field of the test strip.
  • the test strip is inserted into the analyzer either immediately after the application or after an incubation period has passed.
  • the sample is only loaded when the test strip is already in the device. In both procedures, the positioning of the test strip in the measuring device takes place by the user. To ensure precise positioning, the user inserts the test strip until mechanical resistance is felt.
  • the measuring process is triggered by pressing a button.
  • the measuring process is automatically started by inserting the test strip.
  • the analysis process is ended by the manual removal of the test strip.
  • the invention was therefore based on the object of providing a system with which a number of analytical determinations can be carried out without feeding individual test strips from the outside to the measuring device.
  • the determination should also be possible safely if the system was stored in the presence of moisture.
  • the positioning of test elements with the help of the system should take place in such a way that operating errors are largely avoided.
  • a system includes a measuring device and an arrangement of test elements.
  • the measuring device has an insertion device for a storage container which contains two or more test elements.
  • the test elements can be brought to the location of the measurement one after the other.
  • An analysis can be achieved by detectable signals whose signal strength depends on the concentration of the parameter to be determined in the sample. Detectable signals suitable for analysis, e.g. B. optical, electrical or magnetic type known.
  • the radiation source preferably emits light in the visible part of the spectrum. Radiation sources that have a continuous or a discrete spectrum can be used. The emitted radiation can either fall directly onto a test element or be guided through an optical arrangement beforehand.
  • An optical arrangement according to the invention can contain elements such as lenses, mirrors and also components which serve to attenuate areas of the emitted radiation. These are preferably optical filters, but grids or prisms are also possible, which lead to a selection of specific frequencies or frequency ranges.
  • Part of the radiation reflected by the test element is received by the radiation receiver after it has passed through an optical arrangement.
  • Such an optical arrangement can contain the elements described above. It is also within the scope of the invention if reflected radiation falls directly on the radiation receiver.
  • the radiation receiver can stand by photomultipliers, photodiodes, photovoltaic elements and others sensors known in the art can be realized.
  • the signal emitted by the radiation receiver can be processed either directly or after processing by basically known electronic circuits and can be displayed with a display device.
  • a display device according to the invention can, for. B. an analog measuring instrument or preferably a digital display.
  • a reader can also be integrated into the device, which reads in data which are characteristic of the test elements used and / or the analysis to be carried out.
  • the data can be present, for example, on a storage container for test elements or can be supplied to the device separately. Barcode readers, magnetic stripe readers and other known devices are possible as reading devices.
  • Read data can e.g. B. refer to the type of test elements, batch number, expiry date and also production-related fluctuating parameters of the test elements.
  • the data can also relate to the type of analysis to be carried out.
  • the invention includes storage containers for two or more test elements, which contain both a device for transporting test elements and a device for sealing test elements against moisture.
  • a system according to the invention can be implemented, for example, with storage containers for two or more test elements which have an opening which can be closed against moisture by pressure from two opposite sides. It is characteristic of a system according to the invention that it has a storage container in which test elements are kept protected from moisture. The test elements are arranged in a row and are individually protected against moisture. This individual sealing can be achieved by preventing the entry of moisture by pressing against each test element.
  • This pressure mechanism is preferably located inside the storage container so that the test elements are protected against moisture even after the storage container has been removed from the system.
  • a pressure mechanism can be implemented, for example, with springs that are located in the system and have bodies at one end that fit sealingly into a recess in the test element.
  • a test field that is located in a circular recess of a test element can be closed by pressing a hemisphere.
  • the vessel opening or the entire vessel consists of an elastic material so that the vessel opening can be compressed in a simple manner.
  • Preferred materials are plastics, especially polyvinyl chloride, polyethylene, polypropylene and Teflon. Both storage containers are possible, which can be refilled after the test elements have been used up, as well as those which are discarded after emptying.
  • the transport of test elements from the storage container to the location of the sample application can be done on the one hand by a mechanism, for. B. a slide can be reached, on the other hand, the arrangement of the test elements themselves can be used to transport the test elements.
  • a preferred embodiment of the invention also includes that the storage container is designed to be removable from the system.
  • Storage containers according to the invention can likewise have an associated identification, which is either located directly on the storage container or is present separately, but can be clearly assigned.
  • a storage container can, for example, have a bar code or a magnetic strip that is automatically read when the storage container is inserted into the device.
  • the storage container and labeling are present separately but packed together, for example.
  • the identification can then be in the form of a strip with a bar code, a chip card, a radio-frequency identification card (RF-ID chip) and other storage options known in the art.
  • RFID chip radio-frequency identification card
  • the invention also includes a mechanically connected arrangement of test elements which contains predetermined breaking points so that individual test elements can be broken out and removed.
  • a test element after its use, for. B. can be separated from the arrangement of the other test elements by tearing, breaking or kinking.
  • a mechanically coherent arrangement is also possible, in which the test elements are interlocked, as is the case, for. B. is the case with parts of a puzzle.
  • This connection of the test elements enables the entire arrangement of test elements to be moved by moving a test element which is located outside the storage container. A test element outside of the storage container can be detached from the arrangement by movement perpendicular to the direction of transport.
  • the handle or holder is preferably located at least one other test element outside the storage container, so that this test element can be transported with the handle or holder. While the handle or holder is outside the storage container, the moisture-sensitive part of the test element in question can be protected from moisture inside the storage container.
  • Test elements which are shaped in such a way that sealing of the test field against moisture can be achieved by pressing on devices.
  • Test elements according to the invention preferably have a frame made of a material that is mechanically so stable that it allows the test element to be transported in the system according to the invention without the test field being damaged by the transport. Preferred materials are plastics, glasses, cardboards and metals.
  • the frame has a recess for the test field and, in preferred embodiments, it can also have a shape that enables it to be used as a handle or holder.
  • the frame is mechanically connected to the test field, the test field is preferably enclosed in one plane by the frame. The test field can be pressed or glued into the frame.
  • the frame is made of plastic, it is also possible for it to be cast or sprayed around the test field during production.
  • the test field contains several layers or areas which can be used for sample application, which, if necessary, separate cells and in which reactions take place which, in the presence of an analyte to be determined, bring about a detectable change.
  • the test field can in other embodiments such as have described above for the prior art.
  • the test field can be protected against moisture by devices in the system, together with the frame, forming an enclosed space in which the respective test field is located.
  • the frame can, for example, be planar or have elevations on its surface, so that the test field is closed when a device, preferably a plate or a stamp, is pressed onto both the top and bottom of the test element.
  • the test element can also be constructed in such a way that the test field is located in a circular recess in the frame. In this case, the access of moisture to the test field can be prevented by, for example, pressing a ball, a partial ball or a conical cylinder onto the circular depression.
  • a system according to the invention offers the user the advantage that he does not need an external storage container for test strips, since a magazine with test elements is integrated in the system. This renders the manual transport of individual test strips from the storage container into the device, which was necessary in previous systems, superfluous. B. avoided by falling during transport.
  • the test elements can be adequately protected from moisture even after a test element has been removed, so that the test elements can be used up over the course of weeks or months without significant loss of quality.
  • the system is shown in FIG. 2 without the protective flap (2).
  • the storage container (6) for test elements is located in the front part of the system, below the cover (7); it has approximately the shape of a bar and extends over most of the width of the base body.
  • the test elements are transported to the location of the sample application and measurement by a slide (8). Sample application and measurement are carried out at the same location, which is above the measuring opening (10).
  • An optics or, as described above, a radiation source and a receiving element can be located under this measuring opening (10).
  • a test element is located above the measuring opening (10) and is surrounded by a gripping arm (9). The area above the measuring opening (10) can be closed by a protective flap (11).
  • FIGS. 2a and 2b The implementation of a measurement can be explained with the aid of FIGS. 2a and 2b.
  • a storage container (6) filled with test elements is inserted laterally into the system.
  • the slide (8) is moved towards the measuring opening (10) until a test element is in the recess of the Gripping arm (9) is located.
  • the protective flap (11) is opened and analyte liquid is applied to the test field of the test element.
  • the protective flap (11) is closed for the measurement.
  • the measurement can either be started by one of the operating elements (4) or it starts automatically when the protective flap (11) is closed, e.g. B. controlled by a light barrier or a switch which is actuated by the protective flap (11).
  • the end of the measurement can be shown on the display device (5) or indicated acoustically by a signal.
  • the measurement result is shown on the display device (5) and can, if desired, be saved in the system.
  • a used test element can be removed from the system by moving the gripper arm (9) to the position shown in FIG. 2b. The test element automatically falls out of the gripper arm (9). The gripper arm (9) is subsequently brought back into the position shown in FIG. 2a. The system is now ready for a new analytical determination.
  • FIG. 3 shows a storage container (6) for test elements.
  • a number of elevations (12) are visible on the upper side, onto which balls located in the base body (3) of the system press in order to achieve the sealing of the test elements.
  • a test element is located under each of the elevations (12) of the storage container (6) when the magazine is full.
  • the storage container has an outlet opening (13) for test elements, which is located next to the measuring opening (10) when the storage container (6) is inserted.
  • test field (16) is surrounded by the frame (15), which has a circular material elevation (17) on the top and bottom, which enables or improves sealing against moisture.
  • FIG. 3 Another preferred embodiment of a system according to the invention is shown in FIG.
  • the system (30) has a cover flap (31) and a base body (32). Operating elements (33) and a display device (34) are integrated in the base body (32).
  • the storage container for test elements is located below a sealing device (35).
  • the location for measurement and sample application also coincides in this embodiment and is located above the measurement opening (36). During the measurement, the test element is protected against ambient light by a protective flap (37).
  • FIG. 6a shows a storage container (38) for test elements with an arrangement of test elements (39) according to the invention.
  • the storage container (38) has the shape of a thin box, which has only one opening into which the arrangement of test elements (39) can be inserted.
  • the test elements belonging to the arrangement of the test elements (39) have a test field (40), a frame (41) and a holder (42).
  • the test elements are connected to one another, however there are predetermined breaking points (43) at which the test elements can be separated from one another.
  • FIG. 6b also shows an inventive storage container (38) for test elements.
  • the arrangement corresponds to that shown in FIG. 6a, but the test elements (41) are hooked into one another.
  • a pin (44) engages in a recess (45).
  • the test elements (41) can be pulled out of the storage container (38) without separating from one another. However, if a test element is located above the measuring opening (36), it moves towards the measuring opening, whereby the hooking of the pin (44) and the recess (45) is released. The last-mentioned test element can be removed from the system after the measurement, without breaking or kinking being necessary.
  • the mode of operation of the sealing device (35) can be explained with FIG. If a new test element is to be brought into the measuring position, the sealing device (35) clamped in the manner of a bayonet is first moved from the position shown in FIG. 5 to the position shown in FIG. This removes the mechanical pressure from the opening of the storage container. A new test element can be pulled out of the storage container (38) by its holder (42). If the sealing device (35) is moved back into the position shown in FIG. 5, the sides of the storage container (38) are pressed onto one another. Test elements remaining in the storage container (38) and in particular the test fields (40) of these test elements are sealed against moisture by the sealing device (35).
  • the steps for opening and closing the protective flap (37) can be omitted from the above list.
  • the measurement can be started by actuating the operating elements (33) or by detecting the sample application.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biophysics (AREA)
  • Optics & Photonics (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
  • Investigating Or Analyzing Non-Biological Materials By The Use Of Chemical Means (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
EP94105884A 1993-04-23 1994-04-15 System for analysing the contents of liquid samples. Withdrawn EP0621481A3 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE4313253 1993-04-23
DE4313253A DE4313253A1 (de) 1993-04-23 1993-04-23 System zur Analyse von Inhaltsstoffen flüssiger Proben

Publications (2)

Publication Number Publication Date
EP0621481A2 true EP0621481A2 (fr) 1994-10-26
EP0621481A3 EP0621481A3 (en) 1995-10-18

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP94105884A Withdrawn EP0621481A3 (en) 1993-04-23 1994-04-15 System for analysing the contents of liquid samples.

Country Status (4)

Country Link
US (1) US5757666A (fr)
EP (1) EP0621481A3 (fr)
JP (1) JP2594019B2 (fr)
DE (1) DE4313253A1 (fr)

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US6534017B1 (en) 1997-04-11 2003-03-18 Roche Diagnostics Gmbh Test element storage device
DE202012101167U1 (de) * 2012-03-30 2013-07-01 Seramun Diagnostica Gmbh Vorrichtung zum Bestimmen von Proben in einer Probenvolumenanordnung und Ständer für die Vorrichtung
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DE102018208049A1 (de) * 2018-05-23 2019-11-28 Robert Bosch Gmbh Gerüststruktur zum Zusammenwirken mit einer Bildauswertevorrichtung für zumindest einen mindestens eine optochemische Detektierfläche aufweisenden Träger

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JPH06308114A (ja) 1994-11-04
EP0621481A3 (en) 1995-10-18
US5757666A (en) 1998-05-26
DE4313253A1 (de) 1994-10-27

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